Children With Cerebral PalsyVERTEBRALNCT06320288
Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL)
An observational study of Children With Cerebral Palsy, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
Trial summary
During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. Read more about this study
- Who is it for?
- Ages 18 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Cerebral Palsy
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2023to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with cerebral palsy presenting gait pattern disorders receive consultation and/or care (day or full hospitalization) at the Flavigny-sur-Moselle CMPRE.
Who may be able to join
- Children (< 18 years) with cerebral palsy
- GMFCS I to III
- Independent walking with or without technical walking aids (walker, crutches, etc.)
- Able to understand the instructions of various clinical assessments and functional explorations
- Affiliated with a social security scheme
Who cannot join
- Children with cerebral palsy
- Neuro-orthopaedic surgery of the lower limbs or trunk within the last 12 months
- Botulinum toxin A injections within the last 6 months
- Therapeutic intervention targeting trunk control last 6 months
- Typically developing children
- Surgery on lower limbs or trunk last 12 months
- Neurological and/or orthopedic pathology that may influence gait
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
Jonathan Pierret, PhD, +33 3 82 52 6761, jonathan.pierret@ugecam.assurance-maladie.fr
About this study
Official title: Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy
During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP.
- Conditions
- Children With Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | All children will undergo : * A neuro-articular assessment * A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking. * Assessment of gross motor function * Static posturography * Functional assessment of the trunk * Functional assessment of balance | |
| Children with typical development | All children will undergo : * A neuro-articular assessment * A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking. * Static posturography * Functional assessment of the trunk * Functional assessment of balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk and center-of-mass accelerations and acceleration variability
In addition to the zeno walking track, inertial computers will be used to record accelerations of the patient's trunk and center of mass as they walk. One will be attached to the sternum, the other to the lumbosacral hinge, using hypoallergenic double-sided tape. A third will be attached to the patient's shoe to synchronize the data from the treadmill and the inertial units. Acceleration variability is calculated in post-processing.
Measured: At the end of the one-day experimental
Secondary outcomes (3)
Gait Variability Index
A composite score of gait variability based on spatio-temporal parameters, giving an index of gait regularity. The mean reference score is 100, and a score above 100 indicates that the patient is at least as stable as a patient from a healthy population.
Measured: At the beginning of the one-day experimental
Trunk Control Measurement Scale score (TCMS)
The TCMS scale assesses trunk control in the seated position in three dimensions. The maximum (and best) score is 58 points, of which 20 correspond to static balance, 28 to selective movement control and 10 to the ability to perform dynamic extension movements.
Measured: At the beginning of the one-day experimental
Early Clinical Assessment of Balance score
The Early Clinical Assessment of Balance is an evaluative measure used by clinicians to assess balance in the cerebral palsy population. Scoring is on a 0-100 scale where higher scores equate to better balance.
Measured: At the beginning of the one-day experimental
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start20 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320288
- Sponsor's protocol ID
- 2023-A00505-40
- Acronym
- VERTEBRAL
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06320288
- Acronym / sponsor ID
- VERTEBRAL / 2023-A00505-40
- Conditions
- Children With Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | –All children will undergo : * A neuro-articular assessment * A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking. * Assessment of gross motor function * Static posturography * Functional assessment of the trunk * Functional assessment of balance |
| Children with typical development | – | –All children will undergo : * A neuro-articular assessment * A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking. * Static posturography * Functional assessment of the trunk * Functional assessment of balance |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with cerebral palsy presenting gait pattern disorders receive consultation and/or care (day or full hospitalization) at the Flavigny-sur-Moselle CMPRE.
Key inclusion criteria (5 listed)
- Children (< 18 years) with cerebral palsy
- GMFCS I to III
- Independent walking with or without technical walking aids (walker, crutches, etc.)
- Able to understand the instructions of various clinical assessments and functional explorations
- Affiliated with a social security scheme
Key exclusion criteria (7 listed)
- Children with cerebral palsy
- Neuro-orthopaedic surgery of the lower limbs or trunk within the last 12 months
- Botulinum toxin A injections within the last 6 months
- Therapeutic intervention targeting trunk control last 6 months
- Typically developing children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trunk and center-of-mass accelerations and acceleration variability
Time frame: At the end of the one-day experimental
In addition to the zeno walking track, inertial computers will be used to record accelerations of the patient's trunk and center of mass as they walk. One will be attached to the sternum, the other to the lumbosacral hinge, using hypoallergenic double-sided tape. A third will be attached to the patient's shoe to synchronize the data from the treadmill and the inertial units. Acceleration variability is calculated in post-processing.
3 secondary outcomes
Gait Variability Index
Time frame: At the beginning of the one-day experimental
Trunk Control Measurement Scale score (TCMS)
Time frame: At the beginning of the one-day experimental
Early Clinical Assessment of Balance score
Time frame: At the beginning of the one-day experimental
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Cerebral Palsy, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Pierret, PhD (+33 3 82 52 6761, jonathan.pierret@ugecam.assurance-maladie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk and center-of-mass accelerations and acceleration variability (time frame: At the end of the one-day experimental). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.